Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"

• ClinicalTrials.gov Identifier: NCT01945216
• Recruitment Status: Completed
• First Posted: September 18, 2013
• Results First Posted: November 8, 2018
• Last Update Posted: November 19, 2019
• Sponsor: Takeda
• Information provided by (Responsible Party): Takeda

Study Description

Brief Summary:

The purpose of this study is to determine the safety and efficacy of long-term treatment with alogliptin (Nesina) in patients with type 2 diabetes mellitus who responded inadequately to diet therapy and exercise therapy alone, or a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor.

In addition, examining the safety and efficacy of alogliptin in patients with renal impairment, information on the appropriate dosage of alogliptin according to the severity of impaired renal function should be collected.

Condition or disease	Intervention/treatment
Type 2 Diabetes Mellitus Who Have Been Examined at a Medical Institution	Drug: Alogliptin

Detailed Description:

A special drug use surveillance is planned to examine the safety and efficacy of long-term use of alogliptin in patients with type 2 diabetes mellitus under the daily clinical use conditions.

Participants of this surveillance will be patients with type 2 diabetes mellitus who failed to respond adequately to diet therapy and exercise therapy alone or to a combination of diet therapy, exercise therapy, and α-glucosidase inhibitor. The planned sample size is 3,000 subjects.

The usual adult dosage for oral use is 1 alogliptin tablet (25 mg) once daily. Participants will receive the drug as part of routine medical care.

Study Design

• Study Type: Observational
• Actual Enrollment: 3317 participants
• Observational Model: Cohort
• Time Perspective: Prospective
• Official Title: Alogliptin Tablets Special Drug Use Surveillance "Type 2 Diabetes Mellitus: Monotherapy/Combination Therapy With α-GI"
• Actual Study Start Date: July 8, 2010
• Actual Primary Completion Date: October 31, 2015
• Actual Study Completion Date: October 31, 2015

Groups and Cohorts

Group/Cohort	Intervention/treatment
Alogliptin 25mg, tablets, orally, once daily, up to 36 months	Drug: Alogliptin; Alogliptin tablets; Other Name: Nesina; SYR-322

Outcome Measures

Primary Outcome Measures :

1. Number of Participants Who Experience at Least One Adverse Events [ Time Frame: Up to Month 36 ]
2. Change From Baseline in Glycosylated Hemoglobin (HbA1c) [ Time Frame: Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36) ]
   The change in the value of glycosylated hemoglobin (the concentration of glucose bound to hemoglobin as a percent of the absolute maximum that can be bound) collected at month 36 relative to baseline.

Secondary Outcome Measures :

1. Change From Baseline in Fasting Blood Glucose [ Time Frame: Baseline, Months 1, 3, 6, 12, 18, 24, 30, 36 and final assessment (up to Month 36) ]
   The change in the value of fasting blood glucose collected at month 36 relative to baseline.

Eligibility Criteria

• Ages Eligible for Study: Child, Adult, Older Adult
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No
• Sampling Method: Non-Probability Sample

Study Population

Patients with type 2 diabetes mellitus who have been examined at a medical institution

Criteria

Inclusion Criteria:

• Patients with type 2 diabetes mellitus who have not adequately responded to any one of the following therapies:

  1. Diet therapy and exercise therapy alone
  2. In addition to diet therapy and exercise therapy, use of α-glucosidase inhibitor

Exclusion Criteria:

• Patients contraindicated for Nesina

  1. Patients with severe ketosis, diabetic coma or precoma, or type 1 diabetes mellitus (these patients require prompt adjustment of hyperglycemia by fluid infusion and insulin, and hence use of Nesina is not appropriate.)
  2. Patients with severe infection, pre- or post-operative patients, or patients with serious traumatic injury (blood glucose control by insulin injection is desirable for these patients, and hence use of Nesina is not appropriate.)
  3. Patients with a history of hypersensitivity to any ingredient of Nesina

Contacts and Locations

Locations

Japan

Osaka, Japan

Sponsors and Collaborators

Takeda

Investigators

• Study Director: Study Director; Takeda

More Information

• Responsible Party: Takeda
• ClinicalTrials.gov Identifier: NCT01945216
• Other Study ID Numbers: 121-011; JapicCTI-132250 ( Registry Identifier: JapicCTI ); JapicCTI-R171018 ( Other Identifier: JapicCTI )
• First Posted: September 18, 2013
• Results First Posted: November 8, 2018
• Last Update Posted: November 19, 2019
• Last Verified: November 2019

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No
• Plan Description: Takeda makes patient-level, de-identified data sets and associated documents available for all interventional studies after applicable marketing approvals and commercial availability have been received (or program is completely terminated), an opportunity for the primary publication of the research and final report development has been allowed, and other criteria have been met as set forth in Takeda's Data Sharing Policy (see www.TakedaClinicalTrials.com for details). To obtain access, researchers must submit a legitimate academic research proposal for adjudication by an independent review panel, who will review the scientific merit of the research and the requestor's qualifications and conflict of interest that can result in potential bias. Once approved, qualified researchers who sign a data sharing agreement are provided access to these data in a secure research environment.

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No

Keywords provided by Takeda:

Drug therapy

Additional relevant MeSH terms:

Diabetes Mellitus; Diabetes Mellitus, Type 2; Glucose Metabolism Disorders; Metabolic Diseases; Endocrine System Diseases; Alogliptin; Hypoglycemic Agents; Physiological Effects of Drugs; Incretins; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Dipeptidyl-Peptidase IV Inhibitors; Protease Inhibitors; Enzyme Inhibitors; Molecular Mechanisms of Pharmacological Action